Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Olympus Medical Systems Corp Olympus Endoscopes (Multiple Models) [HKMD No.: 200006, 150080, 140190, 160213, 160279, 190144, 140445, 140189, 190371].
According to the Health Canada, following repair activities, the manufacturer uses a water flush of endoscope channels as part of the final endoscope channel inspection, and the manufacturer subsequently dry the endoscope channels with compressed filtered air. The manufacturer discovered that the channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/olympus-endoscopes
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Oct 2023